Target Mitochondrial Fitness, Chronobiology and Metabolism

Healthy Subjects Clinical Trial

— PI19/00507  

Official title:

Target Mitochondrial Fitness, Chronobiology and Metabolism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05600192
• Other study ID #: PI19/00507
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exercise could be an element that affects the biochemical, metabolic and microbiome parameters of organisms. Thus, to identify and validate the effects of aerobic and anaerobic exercises at different times of the day (morning or afternoon) on mitochondrial fitness and whether this changes could have a relation with metabolism and cardiovascular parameters and microbiome is of great interest for its applicability in biomedicine.

As specific objectives of this project will study:

1. - To study the direct effect of aerobic and anaerobic exercise at different time points in the day on mitochondria fitness (short study: basal, at the end of the exercise and 2 h after exercise).

2. - To study mitochondria fitness under morning or afternoon aerobic and anaerobic exercise (prospective study: basal, 4, 8 and 12 weeks of the study).

3. - To identify and validate modulators and target proteins of mitochondria fitness affected by exercise (miRNA omic and proteomic analysis of mitochondria from the different groups of the study at basal and 12 weeks of the study).

4. - To study the relationship of the mitochondrial response (Objectives 1 and 2) to the different combination of exercises and chronobiology with anthropometric-clinical, carbohydrate and lipid metabolic and cardiovascular changes.

5. - To check the effect of morning or afternoon aerobic and anaerobic exercise on gut microbiota and its relation to mitochondria fitness, clinical and metabolic parameters (basal, 4, 8 and 12 weeks of the study).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 20-

• IMC <30 kg/m2

• Informed consent

Exclusion Criteria:

• Smoker

• Previous physical exercise of more than 20 minutes / 2 times a week

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Aerobic or anaerobic exercise
Aerobic or anaerobic exercise in the morning or in the afternoon

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Weight in kg	From baseline to week 12
Primary	BMI (body mass index) changes	Measured by body composition analysis	From baseline to week 12
Primary	Change in waist circumference	Circumference in cm	From baseline to week 12
Primary	Change in hip circumference	Circumference in cm	From baseline to week 12
Primary	Changes in diastolic and systolic blood pressure	To analyze the effect of exercise on blood pressure	From baseline to week 12
Primary	Changes in body composition	To analyze the effect of exercise on anthropometric parameters measured by bioelectrical impedance analysis	From baseline to week 12
Primary	Change in glucose concentration	Glucose in mg/dl	From baseline to week 12
Primary	Change in insulin concentration	Insulin in mg/dl	From baseline to week 12
Primary	Change in glycated haemoglobin concentration	Glycated haemoglobin in mg/dl	From baseline to week 12
Primary	Change in Triglycerides concentration	Triglycerides in mg/dl	From baseline to week 12
Primary	Change in cholesterol concentration	Serum cholesterol in mg/dl	From baseline to week 12
Primary	Change in HDL concentration	Serum HDL in mg/dl	From baseline to week 12
Primary	Change in LDL concentration	Serum LDL in mg/dl	From baseline to week 12
Primary	Change in transaminases concentration	Serum transaminases in UI/l	From baseline to week 12
Primary	Change in creatinine concentration	Creatinine in mg/dl	From baseline to week 12
Primary	Change in uric acid concentration	Uric acid in mg/dl	From baseline to week 12
Primary	Change in alkaline phosphatase concentration	Serum alkaline phosphatase in UI/l	From baseline to week 12
Primary	Change in bilirubin concentration	Serum bilirubin in mg/dl	From baseline to week 12
Primary	Change in lactate concentration	Serum lactate in mmol/L	From baseline to week 12
Primary	Change in cortisol concentration	Serum cortisol in nmol/L	From baseline to week 12
Primary	Change in total and free testosterone concentration	Serum total and free testosterone in nmol/L	From baseline to week 12
Primary	Change in melatonine concentration	Serum melatonine in pg/ml	From baseline to week 12
Primary	Characterize exercise participant behavior	International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) carried out in the last seven days, as well as walking and sitting time in a work day. It evaluates three characteristics of physics (PA): intensity (mild, moderate or vigorous), frequency (days per week) and duration (time per day). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Index Units) per minute and week.	From baseline to week 12
Primary	Mediterranean diet adherence questionnaire	To evaluate adherence to a Mediterranean diet pattern. It consists of 14 items in which different components of the Mediterranean diet are evaluated (number of pieces of fruit consumed per day, number of portions of legumes consumed per week...). Each item is scored as 0 or 1. A total score of <9 indicates poor adherence, while a score of =9 indicates good adherence.	From baseline to week 12
Primary	Change in faecal microbiota	To evaluate faecal microbiota composition in the studied subjects and the effect of aerobic and anaerobic exercise in the morning or afternoon on faecal microbiota composition. 16S rRNA amplicons of fecal community DNA	From baseline to week 12
Primary	Change in fitness mitochondrial	To evaluate the effect of aerobic and anaerobic exercise in the morning or afternoon on mitochondrial fitness, evaluated by mitochondrial gene expression and protein abundance, mitochondrial metabolites, mitochondrial markers trough flow citometry.	From baseline to week 12